Use of Ixmyelocel-T (Formerly Vascular Repair Cells [VRC]) in Patients With Peripheral Arterial Disease to Treat Critical Limb Ischemia

Phase 2

Completed

Brief Summary: This study is designed to evaluate the safety and efficacy of autologous Vascular Repair Cells (VRC) for patients with peripheral arterial disease as a treatment for critical limb ischemia.

The double-blind study is expected to enroll 150 patients, randomized into two patient groups. The treatment group will receive intramuscular (IM) injections of the VRCs into the affected limb; the control group will receive intramuscular injections with an electrolyte solution (without cells). Both groups will receive the standard of care appropriate for their medical condition.

Detailed Description: The study will assess the safety and ability of Aastrom TRC autologous bone marrow cells to restore peripheral blood flow affected by critical limb ischemia.

Peripheral arterial disease (PAD), also known as Peripheral Vascular Disease (PVD), occurs when peripheral arteries are damaged by arterial hypertension and/or by the formation of atherosclerotic plaques. PAD is a chronic disease that progressively constricts arterial circulation of limbs. The term critical limb ischemia (CLI) is used for all patients with chronic ischemia rest pain, ulcers, or gangrene in limbs attributable to objectively proven PAD. These sequelae represent the end stage of PAD. PAD is associated with several other clinical conditions, i.e. hypertension, cardiovascular disease, hyperlipidemia, diabetes, tobacco use, obesity and stroke.

The double-blind study is expected to enroll 150 patients, randomized into two patient groups. The treatment group will receive intramuscular injections of the TRC product into the affected limb; the control group will receive intramuscular injections with an electrolyte solution (without cells). Both groups will receive the standard of care appropriate for their medical condition.

Recruitment & Eligibility

Inclusion Criteria

Males and females, 18-90 years of age
Diagnosis of CLI
Infrainguinal occlusive disease, without options for revascularization
No surgical interventions planned
Life expectancy of 2 years
Normal organ and marrow function
Patients with controlled blood pressure (≤ 180/110 mmHg) and established anti-hypertensive therapy
Established anti-platelet therapy

Exclusion Criteria

Poorly controlled diabetes mellitus (hemoglobin A1c [HbA1c] > 10%)
Aortoiliac disease with > 50% stenosis
Wounds with severity greater than Grade 3 on the Wagner Scale
Any known failed ipsilateral revascularization within 2 weeks of enrollment
Previous amputation of the talus, or above in the target limb
Life-threatening ventricular arrhythmia; unstable angina; or, myocardial infarction within 4 weeks of enrollment
Severe congestive heart failure (CHF) (i.e. New York Heart Association [NYHA] Stage IV)
Receiving treatment with hematopoietic growth factors
Infection of the involved extremity(ies)
Active wet gangrenous tissue
Require uninterruptible anticoagulation therapy
Blood clotting disorder
Cancer
End stage renal disease requiring dialysis for more than 6 months prior to enrollment
Pregnant or lactating
Having received medication for thrombolytic therapy (e.g. rTPA or other enzymatic clot busters) within 30 days prior to enrollment
Undergoing hyperbaric oxygen treatment within 2 weeks of enrollment
Concomitant wound treatments with growth factors or tissue engineered products
Receiving anti-angiogenic drugs

Primary Outcome Measures

Name	Time	Method
Safety of TRCs in patients with CLI(key safety parameters include vital signs, physical exams, laboratory results, assessment of aspiration and injection sites, adverse events, major amputations, wounds presence(size and grading using the Wagner scale)	throughout trial

Secondary Outcome Measures

Name	Time	Method
Composite efficacy endpoint assessing time to treatment failure(failure defined as major amputation, doubling of wound size, and new gangrene)	Day 7 and Months 3, 6, 9, 12
Percentage of patients failing treatment	Day 7, and Months 3,6,9, and 12
Incidence of bypass surgery for patients throughout duration of study	Day 7 and Months 3,6,9,12
Healing of all wounds in the target limb	Day 7 and Months 3,6,9,12
The King's College Vascular Quality of Life Questionnaire	Baseline and Months 6 and 12
Walking distance as measured by six-minute walk test(with or without walking device)	Baseline and Month 12
Time to major amputation	Day 7 and Month 3, 6, 9, and 12
Percentage of patients undergoing major amputation	Day 7 and Months 3, 6, 9, 12
Ankle and/or toe pressure and ankle brachial pressure index and/or toe brachial index	Day 7 and Months 3,6,9,12
Concurrent Meds for trends	Day 7 and Months 3, 6, 9, 12
Incidence of revascularization interventions throughout duration of study	Day 7 and Months 3,6,9,12
Pain, as measured by visual analog scale(VAS)	Day 7 and Months 3,6,9,12

Locations (20): Cardiology, P.C.
🇺🇸
Birmingham, Alabama, United States
Arizona Heart Institute
🇺🇸
Phoenix, Arizona, United States
University of California, San Francisco
🇺🇸
San Francisco, California, United States
Malcolm Randall Veterans Administration Medical Center, part of the North Florida/South Georgia Veterans Health System
🇺🇸
Gainesville, Florida, United States
University of Miami/Miller School of Medicine
🇺🇸
Miami, Florida, United States
Loyola University Stritch School of Medicine
🇺🇸
Maywood, Illinois, United States
Southern Illinois University School of Medicine
🇺🇸
Springfield, Illinois, United States
The Care Group, LLC
🇺🇸
Indianapolis, Indiana, United States
VA Ann Arbor Healthcare System
🇺🇸
Ann Arbor, Michigan, United States
St. Joseph Mercy Hospital
🇺🇸
Ann Arbor, Michigan, United States
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Cardiology, P.C.
🇺🇸Birmingham, Alabama, United States